The following data is part of a premarket notification filed by Cleveland Clinic Foundation with the FDA for The Vanguard System.
| Device ID | K941551 |
| 510k Number | K941551 |
| Device Name: | THE VANGUARD SYSTEM |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | CLEVELAND CLINIC FOUNDATION 9500 EUCLID AVE. Cleveland, OH 44195 |
| Contact | Carol L Schaffer |
| Correspondent | Carol L Schaffer CLEVELAND CLINIC FOUNDATION 9500 EUCLID AVE. Cleveland, OH 44195 |
| Product Code | GWQ |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GWJ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-30 |
| Decision Date | 1995-01-13 |